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Coloplast Manufacturing US, LLC Recall 89029

Description: Torosa Saline-Filled Testicular Prosthesis (Size Small)

Coloplast Manufacturing US, LLC Recall 89029 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0413-2022
Event ID89029
Event DescriptionTorosa Saline-Filled Testicular Prosthesis (Size Small)
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the country of Canada.
Quantity19 units
Recall ReasonProduct is mislabeled for size.
Device Classification20211229
Device Code InfoSKU# 5206102400; Catalo # (450-1325); Lot 7685283
Center Classification Date20211222
Recall Initiation Date20211109
Recalling FirmColoplast Manufacturing US, LLC
Initial Notification Letter
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